With vaccine distribution underway, temperature and data control are essential.

Preparing for the Unexpected

Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.

Vial or Prefilled Syringe?

Genetic vaccine platforms demonstrate their potential.

Innovating to Fight the Pandemic

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The agency will use technology for “voluntary remote interactive evaluations” for pre- and post-approval and other types of inspections.

FDA Weighs in on Remote Inspections

EMA's Pharmacovigilance Risk Assessment Committee is reviewing very rare cases of unusual blood clots in the US, following administration of Janssen’s COVID-19 vaccine.

Safety Review of Janssen COVID-19 Vaccine Continues in Europe

EMA is continuing to monitor the incidences of very rare blood clots with low blood platelets occurring after vaccination with the AstraZeneca COVID-19 vaccine (Vaxzevria).



Further Context on AstraZeneca COVID-19 Vaccine Risks to be Provided by EMA

EMA has started its review of monoclonal antibody VIR-7831 (also known as GSK4182136) as a treatment for patients with COVID-19.

EMA Review of VIR-7831 for COVID-19 Underway

CDC and FDA are reviewing data from reported cases of a rare type of blood clot in people that received the Johnson & Johnson COVID-19 vaccine. 

FDA Recommends Pausing Use of J&J COVID-19 Vaccine After Reports of Blood Clots 

FDA has accepted Airway’s investigational new drug application for the development of its novel human recombinant protein, AT-100 (rhSP-D), as a treatment for COVID-19.

FDA Accepts IND for Airway Therapeutics’ Treatment for Severe COVID-19 Patients

Eli Lilly has modified its purchase agreements with the US government for its emergency use authorized COVID-19 neutralizing antibody therapies, bamlanivimab and etesevimab, to be supplied and used together rather than individually.

Eli Lilly Modifies COVID-19 Purchase Agreement with the US Government

A Phase III clinical trial of anti-coronavirus immunoglobulin did not meet its endpoints, concluding the year-long CoVIg-19 Plasma Alliance, Takeda and CSL Behring announced.

Plasma-Based COVID-19 Treatment Alliance Ends its Project as Trial Fails to Meet Endpoints

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

Catalent Expands COVID-19 Vaccine Fill/Finish Collaboration with Moderna

The first revision further clarifies the number of doses per vial for the vials that are already available, while the second revision allows for the availability of an additional multi-dose vial.

COVID-19 Update

Preparing for the Unexpected

Vial or Prefilled Syringe?

Innovating to Fight the Pandemic